Maiwald, Christian A. and Niemarkt, Hendrik J. and Poets, Christian F. and Urschitz, Michael S. and Koenig, Jochem and Hummler, Helmut and Bassler, Dirk and Engel, Corinna and Franz, Axel R. and Franz, Axel R. and Engel, Corinna and Poets, Christian F. and Hummler, Helmut and Urschitz, Michael S. and Koenig, Jochem and Niemarkt, Hendrik J. and Bassler, Dirk and Engel, Corinna and Maiwald, Christian A. and von Oldershausen, Gabriele and Bergmann, Iris and Weiss, Monika and Wichera, Caroline J. B. R. and Eichhorn, Andreas and Raubuch, Michael and Schuler, Birgit and Schoberer, Mark and Trepels-Kottek, Sonja and Voelkl, Thomas M. K. and Horsinka, Sibylle C. and Hammond, Edmondo N. L. and von Buch, Christoph and Teig, Norbert and Dettmers, Susanne and Koerner, Hans Thorsten and Troeger, Birte and Ander, Annika and Huebler, Axel and Seipolt, Barbara and Mense, Lars and Hoehn, Thomas and Lohmeier, Klaus and Erfurt, Helios Klinikum and Bittrich, Hans-Joerg and Roefke, Kathrin and Esslingen, Klinikum and von Schnakenburg, Christian and Niethammer, Klaus and Fuchs, Hans and Klotz, Daniel and Wolf, Monika and Kabisch, Sarah and Koluch, Anna and Idel, Sandra and Bohnhorst, Bettina and Peter, Corinna and Meyer, Sascha and Sauer, Harald and Lorenz, Kathrin and Kuehr, Joachim and Holz, Sandra and Thome, Ulrich H. and Ackermann, Benjamin W. and Gebauer, Corinna and Celanowski, Catrice and Fahnenstich, Hubert and Kannan, Cecil and Mildenberger, Eva and Kidszun, Andre and Winter, Julia and Maier, Rolf F. and Voss, Hana and Memmingen, Klinikum and Pallacks, Ralf and Lang, Kirsten M. and Gatti, Andre and Hauner, V. and Flemmer, Andreas W. and Herber-Jonat, Susanne and Schwabing, Klinik and Krueger, Marcus and Reber, Daniela and Sandkoetter, Julia and Masjosthusmann, Katja and Urlichs, Florian and Frank, Thomas and Schroth, Michael and Grillhoesl, Christian and Kittel, Jochen and Michel, Holger and Wellmann, Sven and Schneider, Hans-Christoph and Mayer, Anja and Lode, Hans-Martin and Lorenz, Daniel and Bosk, Axel T. and Lindner, Torben and Stuttgart, Klinikum and Vochem, Matthias and Neuberger, Patrick and Franz, Axel R. and Arand, Joerg and Mendler, Marc R. and Essers, Jochen and Bender, Christian and Beckmann, Jessica and Rauch, Ralf and Bernbeck, Ulrich and Glaser, Kirsten and Wirbelauer, Johannes and Kroon, Andre A. and Goos, Tom and Niemarkt, Hendrik J. and Mohns, Thilo and Zwolle, Isala Kliniek and van Straaten, Henrica L. M. and Mulder, Estelle E. M. and Bassler, Dirk and Hesse, Mara (2019) Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO(2)-C) on outcome of extremely preterm infants - study protocol of a randomized controlled parallel group multicenter trial for safety and efficacy. BMC PEDIATRICS, 19 (1): 363. ISSN , 1471-2431
Full text not available from this repository. (Request a copy)Abstract
Background Most extremely low gestational age neonates (ELGANS, postmenstrual age at birth (PMA) < 28 completed weeks) require supplemental oxygen and experience frequent intermittent hypoxemic and hyperoxemic episodes. Hypoxemic episodes and exposure to inadequately high concentrations of oxygen are associated with an increased risk of retinopathy of prematurity (ROP), chronic lung disease of prematurity (BPD), necrotizing enterocolitis (NEC), neurodevelopmental impairment (NDI), and death beyond 36 weeks PMA. Closed-loop automated control of the inspiratory fraction of oxygen (FiO(2)-C) reduces time outside the hemoglobin oxygen saturation (SpO(2)) target range, number and duration of hypo- and hyperoxemic episodes and caregivers' workload. Effects on clinically important outcomes in ELGANs such as ROP, BPD, NEC, NDI and mortality have not yet been studied. Methods An outcome-assessor-blinded, randomized controlled, parallel-group trial was designed and powered to study the effect of FiO(2)-C (in addition to routine manual control (RMC) of FiO(2)), compared to RMC only, on death and severe complications related to hypoxemia and/or hyperoxemia. 2340 ELGANS with a GA of 23 + 0/7 to 27 + 6/7 weeks will be recruited in approximately 75 European tertiary care neonatal centers. Study participants are randomly assigned to RMC (control-group) or FiO(2)-C in addition to RMC (intervention-group). Central randomization is stratified for center, gender and PMA at birth (< 26 weeks and >= 26 weeks). FiO(2)-C is provided by commercially available and CE-marked ventilators with an FiO(2)-C algorithm intended for use in newborn infants. The primary outcome variable (composite of death, severe ROP, BPD or NEC) is assessed at 36 weeks PMA (or, in case of ROP, until complete vascularization of the retina, respectively). The co-primary outcome variable (composite outcome of death, language/cognitive delay, motor impairment, severe visual impairment or hearing impairment) is assessed at 24 months corrected age. Discussion Short-term studies on FiO(2)-C showed improved time ELGANs spent within their assigned SpO(2) target range, but effects of FiO(2)-C on clinical outcomes are yet unknown and will be addressed in the FiO(2)-C trial. This will ensure an appropriate assessment of safety and efficacy before FiO(2)-C may be implemented as standard therapy.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | INTERMITTENT HYPOXIC EPISODES; INSPIRED OXYGEN; SATURATION TARGETS; SEVERE RETINOPATHY; CLINICAL-PRACTICE; CELL-DEATH; PREMATURITY; DISABILITY; HYPOXEMIA; Oxygen; Closed-loop automated control of the inspiratory fraction of oxygen (FiO(2)-C); Infant; premature; Intermittent hypoxemia and hyperoxemia |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Kinder- und Jugendmedizin |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 31 Mar 2020 05:27 |
| Last Modified: | 31 Mar 2020 05:27 |
| URI: | https://pred.uni-regensburg.de/id/eprint/25983 |
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